Arbor Vita Corporation
- Product Manager / Operations / Quality Control Manager
2013 - 2016
Arbor Vita Corporation
- Senior Reseach Associate / Product Development / Quality Control
2012 - 2013Develop QC test procedures (biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles).
Master new assays quickly and apply knowledge for troubleshooting.
Set specifications for Arbor Vita diagnostics reagents/components/product.
Perform QC tests on in-process and final product in a timely and appropriate manner.
Maintain detailed QC records.
Write, revise and review QC procedures, Drawings, Equipment SOP’s and Document Change Orders.
Perform maintenance and calibration on QC equipment/instruments as needed.
Perform IQOQ’s of equipment.
Participate in FMEAs (Failure Modes & Effects Analyses).
Follow 5S principles throughout daily work activities.
Work closely and effectively with R&D, Manufacturing and Quality Assurance departments.
Participate in the development and execution of studies to provide the Quality Control/Product Development departments with information for continuous quality improvement.
Maintain data integrity, ensure documentation and compliance to FDA quality system management 21CFR820.
Adhere to GLP and GMP.
Ensure personal training records are current.
Train employees as needed.
Track general/quality control laboratory supplies and order as needed.
Participated in the process of obtaining approval to affix the CE Mark to the OncoE6™ Cervical Test product (as an IVD).
Arbor Vita Corporation
- Research Associate II
2011 - 2012HPV Diagnostics
Developed a bead-based assay using a FACS platform for the detection of E6 oncoprotein from high risk HPV types.
Techniques included Flow Cytometry, Polystyrene bead-conjugation with Monoclonal Antibody, and Monoclonal Antibody conjugation (biotinylation, AP, FITC, PE).
Arbor Vita Corporation
- Research Associate I
2010 - 2011HPV Theurapeutics
Tested candidate small molecule for binding to PDZ domains via biochemical test, and elucidating effects in cell based assays.
Handling several mammalian cell lines (cancer and non-cancer cells) and used them on viability (ATP quantification) or apoptosis (Caspase activity, PARP detection, DNA fragmentation quantification) assays.
Realized transient transfections (Calcium Phosphate precipitation) on cells.
Used of Flow Cytometry techniques (FACS with TUNEL method), intracellular staining (FITC, PI, APC), Bradford and A280 protein quantification, SDS-PAGE, Western blot or In cell Western (immunofluorescence or HRP detection).
Arbor Vita Corporation, Fremont, CA, USA
- Research Associate Intern
2009 - 2010Engineering internship in the R&D department of the Human Papillomavirus (HPV) team
Developed a prototype rapid E6 protein based diagnostic assay for pre-cancer and cancer caused by HPV type 35. Used immuno-chromatographic lateral flow test (strip test), competitive ELISA tests and growth of mammalian cells.
Recorded materials, methods, results and analysis in laboratory notebook.
Delivered weekly presentations of results and work in progress.
Famille Michaud Apiculteurs/ Lune de Miel, Gan, France
- Stage Technicien
2008 - 2008Travail dans le laboratoire de control qualité du miel.
Utilisation de tests ELISA de compétition, réfractométrie et HPLC (Accela, ThermoElectron Corporation) avec le logiciel d'exploitation associé:ChromQuest.